Pharma R&D Today
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Transparency for Better Science
Posted on February 10th, 2016 by Betsy Davis in Pharma R&D
I like to think of scientific discovery as not unlike parenthood: scientists create a piece of knowledge (like a child), and then release it to its own life in the world (a grown-up child), and, often, that piece of knowledge informs the discovery of another piece of knowledge, until there’s a whole family tree of scientific discoveries that begat others. Sir Issac Newton expressed a similar idea when he said, “If I have seen further it is by standing on the shoulders of giants.” And so the scientific community is one that transcends space and time, but collectively moves toward greater knowledge, insight, and wisdom. But does it do so as quickly and efficiently as possible?
A few days ago, National Public Radio here in the US aired and published a story called, “Journal Editors To Researchers: Show Everyone Your Clinical Data”. In it, Harlan Krumholz, a cardiologist and the Harold H. Hines Jr. Professor of Medicine at Yale School of Medicine, discusses the proposal put forth last week by leading journal editors called “Sharing Clinical Trial Data: A Proposal From the International Committee of Medical Journal Editors” and published in Annals of Internal Medicine. The document proposes,
As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication.
The committee also posits, at the end of their two-page proposal:
Sharing data will increase confidence and trust in the conclusions drawn from clinical trials. It will enable the independent confirmation of results, an essential tenet of the scientific process. It will foster the development and testing of new hypotheses. Done well, sharing clinical trial data should also make progress more efficient by making the most of what may be learned from each trial and by avoiding unwarranted repetition. It will help to fulfill our moral obligation to study participants, and we believe it will benefit patients, investigators, sponsors, and society.
The data submission requirements would be a huge step to improving medical and pharmaceutical research; it can certainly help improve a great deal of the information upon which clinicians ultimately act. It’s old news that virtually every component of research can influence the end result away from the absolute truth – and that includes the way in which data was analyzed. Allowing others to see the original data will allow for checking of the analyses to determine whether there are potential alternative conclusions, undo any false claims, expose any undisclosed negative findings, and allow for validation without repeated research involving more patients, and without delaying access to promising treatments.
While speaking recently with a former R&D scientist, the comment was made about a leading mind in her previous area of research: “He said he would rather be first than right, and by the time anyone figured out he was wrong, he would have moved on to the next Big Thing.” She didn’t disclose his name, but mentioned he was a frequent consultant and key opinion leader in the pharmaceutical industry. This type of nefarious mindset is certainly rare in the industry – or anywhere – but the damage of such minds can be widespread nonetheless. How many genuine findings have been delayed by research rabbit holes that could have been proven wrong earlier?
As David H. Freedman says in The Atlantic feature Lies, Damned Lies, and Medical Science, albeit from 2010, even if it’s just a minority of researchers who allow their desire to see certain results compromise the integrity of the scientific process, their findings can have an outsize effect on published research. After all, it’s the work of those who prove the eye-catching theories that everyone talks about – not the work of the more principled scientists who disprove them.
In the article, Freedman profiles the research of Dr. John Ioannidis, who has dedicated himself to exposing bad science. “Even when the evidence shows that a particular research idea is wrong, if you have thousands of scientists who have invested their careers in it, they’ll continue to publish papers on it,” Dr. Ioannidis is quoted as saying. “It’s like an epidemic, in the sense that they’re infected with these wrong ideas, and they’re spreading it to other researchers through journals.”
Furthermore, Freedman suggests, “the peer-review process often pressures researchers to shy away from striking out in genuinely new directions, and instead to build on the findings of their colleagues (that is, their potential reviewers) in ways that only seem like breakthroughs.” Scientists are supposed to be ensuring the validity of each other’s results through retesting, but the reality is that they just don’t do it very often.
Needless to say, your average person knows none of this as they read short blurbs about the latest scientific studies in the newspaper or take advice from their doctor. But this lack of integrity and transparency in the lab ultimately affects patients, as they put their trust in drugs, treatments, or recommendations that they believe to have passed rigorous tests in trials and studies.
The secretiveness of clinical trials can also be a problem for those who participate in them. In another article in The Atlantic, a woman named Emma Yaskinski explains that as a young child she took part in a clinical trial that aimed to fix a hole in her heart by inserting a device into it. While it appeared to have worked (after all, Yasinski is still with us today), she made the rather stunning revelation that all evidence to do with her trial has basically vanished over the years, leaving her with no idea whether or not the trial was considered a success or if the device was approved and in use.
Fortunately, since then, the ClinicalTrials.gov registry has been developed and, Yasinski reports, both federal law and pressure from the scientific community is encouraging researchers to register their results. However, the information in the registered studies can be woefully incomplete. And if the trial fails, results don’t have to be reported at all.
The proposal made by journal editors wishing to see more open data-sharing in clinical trial research could be an excellent step in the right direction. Yasinski also notes that the NIH and the Department of Health and Human Services have proposed that results from all trials (whether FDA approved or not) need to be reported on ClinicalTrials.gov.
If these proposals gain traction, it’s better for everyone. Because, in the end, transparency in data can only lead to better research. After all, how can our Newtons of today improve upon others’ research if they can’t even see it?
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